Sequenced Treatment Alternatives to Relieve Depression (STAR*D). Part 1: study design.

This article describes the design of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. The main study objective was to compare the efficacy and tolerability of various antidepressant therapies through four sequential treatment levels. To maximize the generalizability of the results, broad inclusion and minimal exclusion criteria were used to recruit patients with major depression from a large number of real-world settings. The goal of treatment was to achieve full remission. A measurement-based care system was used to guide and optimize treatment at each level. Patients were treated for up to 12 weeks at each level (with an optional week 14 visit, if needed). All patients started with citalopram at Level 1. The three subsequent levels of treatment options were randomized and open label, and patients could accept or decline treatments as long as sufficient options were left that allowed randomization between at least two different options. For any treatment level, patients who reached full remission, and those with satisfactory response, could continue the same treatment during 1-year naturalistic follow up. Patients who did not reach full remission were encouraged to enter subsequent levels.

RCT Entities:   Population Interventions Outcomes